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  • Jefferson Adams
    Jefferson Adams

    FDA Sued for Failing to Keep Gluten Out of Medicines

    Reviewed and edited by a celiac disease expert.

    Caption: Photo: CC--Sponge

    Celiac.com 03/18/2015 - A man who suffers from celiac disease has sued the FDA for allowing gluten to be used as a coating on prescription drug and over-the-counter medicine capsules.

    Remember, people with celiac disease can suffer intestinal damage when they consume gluten. This can damage can lead to neurological, among other disorders.

    The man, Michael Weber, was taking a generic drug seven years ago, and developed side effects consistent with ingesting gluten.

    Weber says he was unable to determine the drug’s gluten status through his pharmacist, and

    Weber went on to petition the FDA to either eliminate wheat gluten in medicines or require new labeling on drugs containing the protein.

    In 2011, the FDA sought public comments about the issue. In 2014, the FDA issued gluten-free definitions and labeling standards for commercial foods, but has failed to act on drugs. So Weber has now filed a lawsuit to demand the FDA do something. The complaint can be read here.

    This raises a couple of questions: Do people with celiac disease deserve to know if there is gluten in their medicine? Do they deserve access to medicines that are gluten-free? Should the FDA definitions and labeling standards also apply to drugs and medicines?


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    I hope the FDA will now act on gluten in medicine. I can no longer tell if I've been glutened at least in the short term. I don't worry about food only my meds. I will have no way of telling until I've been poisoned for several days. I keep tract of my medicine and when I open a new bottle. It would be so nice if I didn't have to worry about my medicine making me sick.

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    Thank you Michael Weber. Over the counter and prescription medicines are a real problem for me as well as many other celiacs. I hope his actions get us moving forward on this key issue.

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    Yes, absolutely! I can't believe they haven't done it yet. It is so hard for people like us with celiac disease to stay safe. I also had a thyroidectomy October 2013, therefore I must take hormone replacement for the rest of my life, and even those medicines are iffy. I just stopped taking liothyronine by Sigma Pharm, because I've been really sick lately....who knows There's probably gluten in it!

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    Absolutely, my daughter and I are extremely sensitive to gluten the drug companies should show us some respect and either get rid of the wheat/gluten all together or at least identify it on their labels.

    I will say my pharmacist is very patient with me when looking up ingredients but it should not be this difficult.

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    Yes. If a drug had peanuts in it for some reason wouldn't they list it because people with a peanut allergy could die. Well so can those with celiac if they keep damaging their intestines.

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    My daughter has celiac disease and I also was amazed that it is so hard to determine from a medicine's label if it has gluten in it. A technician at our pharmacy does his best to find out what he can for us with prescription drugs, but we don't always feel certain. Also, trying to find out if an over-the -counter cold medicine is gluten-free from the label is almost impossible. In sum, we would love medicines to be gluten-free, but at the least we believe labeling on medicines should be such that you can discern whether a drug has gluten or not.

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    I totally agree, we need to know if gluten is in our meds. I have had problems with prescription meds that I have taken for years change their formulas. The happened with Cimbalta. They added gluten, I got really sick. It took me almost 3 months to figure out why I had the reaction. Finally realized it was a prescription The drug company was many times, no answer as to if the Cimbalta had been changed. They finally contacted my pharmacy and told them they had changed the formula. My pharmacy tried for the 3 months, took the drug company that long to admit the formula change. Drug companies need to be more concerned about the problems from gluten on celiac patients.

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    Absolutely!!! Especially with so many insurance companies requiring that you use the generic version, it can be a real problem if the generic has gluten and the name brand doesn't. That information should be readily accessible. Big Pharma and insurance companies need to understand the problem that their substitution can cause for individuals sensitive to gluten. Plus the people that you are required to contact need to be educated to understand that any gluten can be a problem for some people.

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    Guest glenda hendrix

    Posted

    I have had this issue since I was diagnosed in 2009 with celiac disease. I tried to get the brand name medications because they usually do NOT contain gluten. My insurance company refused to pay for the brand medication even with a letter from my GI MD! I too have asked the Pharmacist about the gluten content of medications, they have no clue! You, as the patient have to do your own research to find the drug company, the phone number and if you are lucky, they will tell you the gluten content! I have had a few that said it was none of my business and would not tell me!I I really try my best not to get contaminated in any way but with medications you do NOT have any control! The generics are changed at the pharmacy based on availability and price! You may have a gluten-free one for a few months then one with Gluten!! I have found TEVA medications, from Israel, almost all of their medications are gluten-free! You have to read the labels on the OTC medications and know the "hidden" terms for gluten to know if they are gluten-free!

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    Yes, when diagnosed with celiac I was given a list of supplements I needed to take. Right from the start I was diligent with my diet and couldn't figure out why I was still feeling poorly. It was the gluten in my vitamins! What's a girl to do? I need the extra supplements but they make me feel horrible or I don't take them and compromise my health.

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    I fell and severely shattered my arm. In the ER they gave me IV pain meds..then had to give anesthesia block to put arm in cast till next day surgery. A sedative was also used. In ER I repeatedly vomited and wretched. 3 weeks later and a total of 90 yes 90 vomit episodes and brain fog pain I knew was glutened by IV meds. Docs said impossible. I researched and found that some drugs IV wise are filtrated with gluten. Then pill pain meds did same reaction..not even narcotics...so I called Teva pharmaceuticals...could not guarantee spelt contamination. The med was on gluten free list.

    I stopped it and was way less sick 24 hours later

    and each day since is less glutened symptoms.

    I lost almost 10 pounds from loss if appetite and vomiting. The bloodstream is bloodstream.. if diabetic and eat too much sugar..that glucose effects organs blood and ultimately bloodstream. I cannot separate one blood route from another or else our other organs systems in any disease would not take such a hit.

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    It is a very serious requirement to know what is in the medicines taken by people with food intolerances...and today this information takes a significant effort to obtain...and if you do succeed in getting an answer, it may be wrong. These materials are toxic to us. The information is required for us to live. It takes me a month to purge my intolerant proteins from my body. If I have a new prescription by the time I find out if it won't make me worse, the need is usually reduced to the point where I don't need it. Very helpful - not.

     

    I am also intolerant to soy. Soy is common in the capsule. We need a lot of progress in this area. The problem is the FDA is supported by the industry they serve --not taxes. So styrene is allowed in our food stream (meat trays) styrene is a strong carcinogenetic, but given enough money you can get anything approved. The does a good job of meat inspection, but medicine - they are not a partner of the public.

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  • About Me

    Jefferson Adams is Celiac.com's senior writer and Digital Content Director. He earned his B.A. and M.F.A. at Arizona State University, and has authored more than 2,000 articles on celiac disease. His coursework includes studies in science, scientific methodology, biology, anatomy, medicine, logic, and advanced research. He previously served as SF Health News Examiner for Examiner.com, and devised health and medical content for Sharecare.com. Jefferson has spoken about celiac disease to the media, including an appearance on the KQED radio show Forum, and is the editor of the book "Cereal Killers" by Scott Adams and Ron Hoggan, Ed.D.

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